Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

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The Complex Anatomy Of An ADC Tech Transfer

Unlike traditional biologics tech transfer, antibody-drug conjugates have many more moving parts. Here are some of the unique challenges that require close attention.

GUEST COLUMNISTS

A Much-Improved Approach For Understanding And Managing Safety Risks
Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.
CSV Assumes The AI System Sits Still — It Doesn't.
The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.
July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.
In Bioprocessing, Trusted Data Is A Process Variable
As digital systems become increasingly interconnected, digital validation ensures systems generating and managing GxP data remain accurate, consistent, and trustworthy.
Combination Cell Therapy's Clinical Success Hinges On Manufacturability
Cell therapy could help unlock checkpoint inhibitors’ potential in solid tumors, but combination regimens raise the bar for manufacturing consistency and scalability.
Are Biopharma Companies Outsourcing Their Ability To Think?
Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.
June 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
In LVV manufacturing, the quality target product profile and the DRM are designed to work together. One defines what is being governed, the other names who governs it.

PHARMA OUTSOURCING WHITE PAPERS

Empowering Antibody Discovery With ProSpeed™
Integrating linear expression technology into single B cell workflows accelerates antibody discovery, enabling early functional screening, improved sensitivity, and cost-effective identification of diverse therapeutic candidates.

Unlocking Durable Allogeneic Cell Therapy
Advances in genome engineering and immune evasion are enabling scalable, durable allogeneic cell therapies, overcoming rejection challenges and expanding potential treatments across diverse diseases.
Tailoring Viral Clearance Study Design
Viral‑clearance studies need phase‑appropriate design, strong virus stocks, modality‑specific risk assessment, and alignment with evolving regulations for reliable safety outcomes.
Set Your Cell And Gene Therapy Program Up For Success From Day One
Partner with a specialized CDMO early in your CGT development to ensure a streamlined path from discovery to successful commercialization, avoiding costly pitfalls and delays.
Nose To Brain (N2B) Drug Delivery – Benefits And Challenges
Delve into the growing interest in drug delivery methods that target the brain and central nervous system via absorption into the bloodstream, specifically focusing on crossing the blood-brain barrier (BBB).
Mastering Pharmaceutical Cleaning Validation Methods
View the basics of cleaning validation and discuss the support services you should seek from your critical cleaning products supplier to optimize your cleaning validation process.